Implantable medical device such as an anastomosis device

ABSTRACT

A medical device which can be implanted at a target site in a living body. The device includes an inner flange formed by radial expansion of the device and an outer flange formed by axial compression of the device. The device can include an implant portion and a discard portion which separate from each other during formation of the outer flange. The separation can occur by fracturing a frangible linkage or by mechanically separating a portion of the outer flange from a deployment tool. The device can be a one piece anastomosis device for connecting a graft vessel to a target vessel without the use of conventional sutures. The inner and outer flanges capture the edges of an opening in a target vessel and secure the graft vessel to the opening in the target vessel. The device greatly increases the speed with which anastomosis can be performed over known suturing methods.

This application is a continuation-in-part of application Ser. No.09/314,278, filed May 18, 1999.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The invention relates to an implantable medical device such as ananastomosis device and a deployment system for implanting the device. Ina preferred embodiment, the device can be used for forming a suturelessconnection between a bypass graft and a blood vessel.

2. Brief Description of the Related Art

Vascular anastomosis is a procedure by which two blood vessels within apatient are surgically joined together. Vascular anastomosis isperformed during treatment of a variety of conditions including coronaryartery disease, diseases of the great and peripheral vessels, organtransplantation, and trauma. In coronary artery disease (CAD) anocclusion or stenosis in a coronary artery interferes with blood flow tothe heart muscle. Treatment of CAD involves the grafting of a vessel inthe form of a prosthesis or harvested artery or vein to reroute bloodflow around the occlusion and restore adequate blood flow to the heartmuscle. This treatment is known as coronary artery bypass grafting(CABG).

In the conventional CABG, a large incision is made in the chest and thesternum is sawed in half to allow access to the heart. In addition, aheart lung machine is used to circulate the patients blood so that theheart can be stopped and the anastomosis can be performed. During thisprocedure, the aorta is clamped which can lead to trauma of the aortictissue and/or dislodge plaque emboli, both of which increase thelikelihood of neurological complications. In order to minimize thetrauma to the patient induced by conventional CABG, less invasivetechniques have been developed in which the surgery is performed throughsmall incisions in the patients chest with the aid of visualizingscopes. Less invasive CABG can be performed on a beating or stoppedheart and thus may avoid the need for cardiopulmonary bypass.

In both conventional and less invasive CABG procedures, the surgeon hasto suture one end of the graft vessel to the coronary artery and theother end of the graft vessel to a blood supplying vein or artery. Thesuturing process is a time consuming and difficult procedure requiring ahigh level of surgical skill. In order to perform the suturing of thegraft to the coronary artery and the blood supplying artery the surgeonmust have relatively unobstructed access to the anastomosis site withinthe patient. In the less invasive surgical approaches, some of the majorcoronary arteries including the ascending aorta cannot be easily reachedby the surgeon because of their location. This makes suturing eitherdifficult or impossible for some coronary artery sites. In addition,some target vessels, such as heavily calcified coronary vessels, vesselshaving very small diameter, and previously bypassed vessels may make thesuturing process difficult or impossible.

An additional problem with CABG is the formation of thrombi andatherosclerotic lesions at and around the grafted artery, which canresult in the reoccurrence of ischemia. The thrombi and atheroscleroticlesions may be caused by the configuration of the sutured anastomosissite. For example, an abrupt edge at the anastomosis site may cause morestenosis than a more gradual transition.

Accordingly, it would be desirable to provide a sutureless vascularanastomosis device which easily connects a graft to a target vessel. Itwould also be desirable to provide a sutureless anastomosis device whichis formed of one piece and is secured to the target vessel in a singlestep.

SUMMARY OF THE INVENTION

According to a preferred embodiment, the present invention relates to ananastomosis device for connecting an end of a graft vessel to a targetvessel wherein the device cooperates with a deployment tool forconnecting an end of the graft vessel to the target vessel. Theanastomosis device comprises a first linkage deformable by thedeployment tool to form a first flange (e.g., an inner flange whichconnects the graft vessel to an inner surface of the target vessel), anoptional connecting portion extending from the first linkage, and asecond linkage deformable by the deployment tool to form a second flange(e.g., an outer flange which connects the graft vessel to an outersurface of the target vessel), the second linkage including deformablelinks which cooperate with a distal end of the deployment tool to formthe second flange. The anastomosis device is preferably sized to fitthrough an incision in the target vessel such that the first flangecomprises an inner flange which presses a portion of the graft vesselinto intimate contact with an inner surface of the target vessel and thesecond flange comprises an outer flange which presses another portion ofthe graft vessel into intimate contact with an outer surface of thetarget vessel.

The anastomosis device can include various features. For instance, aconnecting portion can be provided between the first and second linkagesand the first and second linkages can include axial members havingweakened areas which cause the axial members to bend simultaneouslyduring formation of the inner and/or outer flange. The deployment toolcan include an expander which forms the first flange and a holder tubesurrounding the expander, the holder tube engaging the deformable linksand bending the deformable links outwardly to form the second flange.

The deployment tool can incorporate various features. For example, adeforming crown tool can include first members and the deformable linkscan include second members which remain connected to the first membersduring formation of the first flange and disconnect from the firstmembers during formation of the second flange, the deformable membersbending the deformable links outwardly during formation of the secondflange and returning to a non-bent configuration after formation of thesecond flange. The first members can comprise tabs and the secondmembers can comprise slots which engage the tabs and openings whichdisengage the tabs, the slots extending from the openings towards aproximal end of the anastomosis device. A deforming crown deploymenttool can include deformable members at the distal end thereof, thedeformable members being plastically deformed after bending thedeformable links outwardly to form the second flange. In a thirdembodiment, the deployment tool breaks off part of the anastomosisdevice during formation of the outer flange. For example, theanastomosis device can include a deployed portion (implant) and aseverable portion (discard) wherein the first and second flanges areformed on the deployed portion and the severable portion is severed fromthe deployed portion when the second flange is formed. The deployedportion can be connected to the severable portion by shearableconnectors and the shearable connectors can be located at pivotconnections between the deployed portion and the severable portion. Theseverable portion and the deployed portion are preferably machined froma single piece of metal and the pivot connections can comprise thinsections of the metal extending between the deployed portion and theseverable portion.

The anastomosis device can incorporate various structural features. Forinstance, the first linkage can include a plurality of struts arrangedin a configuration such that an axial dimension of the first linkagechanges upon radial expansion of the first linkage. Further, the firstlinkage can include a plurality of piercing members which penetrate thegraft vessel. The second linkage can include a plurality of axialmembers and struts arranged in a configuration such that radialexpansion of the second linkage does not cause formation of the secondflange. The second linkage can also include pairs of axial members whichare closer together at a distal end thereof than at a proximal endthereof, the proximal ends of the axial members being joined bycircumferentially extending severable links to a linkage supported bythe tool, the severable links being severed when the second flange isformed.

An anastomosis device deployment system according to the invention caninclude a handle and a holder tube attached to the handle, the holdertube having a distal end configured to hold the anastomosis device withan attached graft vessel; and an expander positioned within the holdertube and slidable with respect to the holder tube to a position at whichthe expander is positioned within the anastomosis device and radiallyexpands the anastomosis device. The system can further include a trocarmovable with respect to the holder tube to form an opening in a targetvessel to receive the anastomosis device and attached graft vessel. Thetrocar can be a split trocar which is slidable over the holder tube andthe expanded anastomosis device. The handle can include cam grooveswhich cooperate with followers of the holder tube and expander to movethe holder tube and expander with respect to one another upon activationof a trigger of the handle. The distal end of the holder tube caninclude a plurality of slits, loops and/or flexible fingers for engagingtabs of the anastomosis device during formation of the inner and outerflanges.

According to another embodiment of the invention, the frangible linkagecan be used to release an implant portion of a medical device at atarget site in a living body. According to this embodiment, the medicaldevice cooperates with a deployment tool for delivering and deployingthe medical device to the site. The medical device includes first andsecond sections connected together by a frangible linkage, the frangiblelinkage being deformable by the deployment tool such that frangibleelements of the frangible linkage are broken and the first section isseparated from the second section. The frangible elements can includeweakened areas which cause the frangible elements to bend when thefrangible linkage is deformed by the deployment tool. For instance, themedical device can comprise an anastomosis device and the first sectioncan include hinged axial members which bend outwardly and form first andsecond flanges. The deployment tool can include an expander which formsthe first flange and a holder tube surrounding the expander, the holdertube engaging the second section and forming the second flange whileseparating the first section from the second section.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention will now be described in greater detail with reference tothe preferred embodiments illustrated in the accompanying drawings, inwhich like elements bear like reference numerals, and wherein:

FIG. 1 is a perspective view of a first embodiment of an anastomosisdevice in a configuration prior to use with a graft vessel everted overthe device;

FIG. 2 is a perspective view of the anastomosis device of FIG. 1 in adeployed configuration;

FIG. 3 is a perspective view of an anastomosis device deployment system;

FIG. 4 is an enlarged perspective view of the distal end of theanastomosis device deployment system of FIG. 3 with an anastomosisdevice prior to deployment;

FIG. 5 is a side cross sectional view of the anastomosis devicedeployment system puncturing the target vessel to advance theanastomosis device into the target vessel wall;

FIG. 6 is a side cross sectional view of the anastomosis devicedeployment system advancing the anastomosis device into the targetvessel wall;

FIG. 7 is a side cross sectional view of the anastomosis devicedeployment system with an expanded first annular flange;

FIG. 8 is a side cross sectional view of the anastomosis devicedeployment system expanding a second annular flange;

FIG. 9 is a schematic side cross-sectional view of a deployment tooltaken along line A—A of FIG. 3, the deployment tool is shown during avessel puncturing step;

FIG. 10 is a schematic side cross-sectional view of the deployment toolof FIG. 9 shown during an anastomosis device insertion step;

FIG. 11 is a schematic side cross-sectional view of the deployment toolof FIG. 9 shown during an anastomosis device expansion step;

FIG. 12 is a schematic side cross-sectional view of the deployment toolof FIG. 9 shown after the anastomosis device has been fully deployed;

FIG. 13 is a perspective view of a frangible anastomosis device in aconfiguration prior to use;

FIG. 14 is a perspective view of the device shown in FIG. 13 afterradial expansion thereof;

FIG. 15 shows a frangible link from the portion of FIG. 14 within thecircle labeled A;

FIG. 16 shows the frangible link of FIG. 15 in a bent configuration;

FIG. 17 shows a variation of the frangible link shown in FIG. 15;

FIG. 18 shows another variation of the frangible link shown in FIG. 15;

FIG. 19 shows a deforming crown design wherein the outer flange of thedevice is formed from frangible helical members;

FIG. 20 shows a deforming crown design wherein the outer flange isformed from members which are mechanically attached to the tool;

FIG. 21 shows how the members forming the outer flange are released fromthe deforming crown during formation of the outer flange;

FIG. 22 shows (in planar form) a variation of the frangible anastomosisdevice shown in FIG. 13;

FIG. 23 shows details of a frangible link arrangement of the deviceshown in FIG. 22;

FIG. 24 shows (in planar form) a variation of the frangible anastomosisdevice shown in FIG. 13;

FIG. 25 shows details of a frangible link arrangement of the deviceshown in FIG. 24;

FIG. 26 shows (in planar form) a variation of the frangible anastomosisdevice shown in FIG. 13;

FIG. 27 shows details of a frangible link arrangement of the deviceshown in FIG. 26;

FIG. 28 shows (in planar form) a variation of the frangible anastomosisdevice shown in FIG. 13;

FIG. 29 shows details of a frangible link arrangement of the deviceshown in FIG. 28;

FIGS. 30 and 31 show details of a tissue anchoring arrangement;

FIG. 32 shows details of how an anastomotic device in accordance withthe invention can be deployed; and

FIGS. 33 and 34 show a further embodiment of the anastomotic device.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

According to the invention it is possible to perform a variety ofanastomosis procedures, including coronary artery bypass grafting. Theterm “target vessel” is thus used to refer to vessels within the patientwhich are connected to either or both of the upstream and downstream endof the graft vessel. In such procedures, a large vessel anastomoticdevice is used with large diameter target vessels such as the aorta orits major side branches or a small vessel anastomotic device is used fora target vessel which has a small diameter such as a coronary artery.

In deploying a large vessel anastomotic device, the device (with one endof a graft vessel attached thereto) is inserted into an incision in awall of the target vessel with a deformable section in a firstconfiguration, and the deformable section is radially expanded to asecond configuration to deploy a flange. The flange applies an axialforce against the wall of the target vessel. Additionally, the flangecan be configured to apply a radial force, substantially transverse tothe device longitudinal axis, against the wall of the target vessel, tosecure the device to the target vessel. For example, the device can havea plurality of deformable sections forming distal and proximal flanges.With the proximal and distal end flanges deployed, the device can beprevented from shifting proximally out of the target vessel or distallyfurther into the interior of the target vessel.

The large vessel devices can be configured to connect to target vesselsof various sizes having a wall thickness of at least about 0.5 mm, andtypically about 0.5 mm to about 5 mm. In a preferred embodiment of theinvention, the large vessel anastomotic device is configured tolongitudinally collapse as the deformable section is radially expanded.The surgeon can control the longitudinal collapse to thereby positionthe distal end flange at a desired location at least partially withinthe incision in the target vessel wall. The surgeon can also control theposition of the proximal end flange by longitudinally collapsing thedevice to a greater or lesser degree, to thereby position the proximalend flange at a desired location in contact with the target vessel.Thus, regardless of the thickness of the target vessel wall, the devicecan be longitudinally collapsed to position the flanges against thetarget vessel wall and effectively connect the device thereto. Thisfeature is significant because the device must be connected to targetvessels which have a wide range of wall thickness. For example, theaortic wall thickness is typically about 1.4 mm to about 4.0 mm and theaorta diameter can range from about 25 to about 65 mm in diameter.Therefore, regardless of the thickness of the target vessel wall, thedegree of deployment of the proximal end flange, and thus thelongitudinal collapse of the device, can be controlled by the physicianto thereby effectively connect the device to the target vessel. Forexample, the surgeon may choose between partially deploying the proximalend flange so that it is positioned against an outer surface of thetarget vessel wall, or fully deploying the flange to position it incontact with the media of the target vessel wall within the incision inthe target vessel wall.

In deploying a small vessel anastomotic device, the device can be usedon small target vessels having a wall thickness of less than about 1.0mm, and typically about 0.1 mm to about 1 mm in the case of coronaryarteries. Despite the small size of the target vessels, the small vesseldevices provide sutureless connection without significantly occludingthe small inner lumen of the target vessel or impeding the blood flowtherethrough. For example, the small vessel devices can include an outerflange (with the graft vessel connected thereto) loosely connected to aninner flange before insertion into the patient with the space betweenthe loosely connected inner and outer flanges being at least as great asthe wall thickness of the target vessel so that the inner flange can beinserted through an incision in the target vessel and into the targetvessel lumen, with the outer flange outside the target vessel. With theouter and inner flanges in place on either side of a wall of the targetvessel, tightening the flanges together compresses a surface of thegraft vessel against the outer surface of the target vessel. Thisconfiguration forms a continuous channel between the graft vessel andthe target vessel, without the need to suture the graft vessel to thetarget vessel wall and preferably without the use of hooks or barbswhich puncture the target vessel.

In a coronary bypass operation in accordance with the invention, a largevessel device can be used to connect the proximal end of the graftvessel to the aorta, and a small vessel device can be used to connectthe distal end of the graft vessel to an occluded coronary artery.However, in patients with an extreme arteriosclerotic lesion in theaorta, which may result in serious complications during surgicalprocedures on the aorta, the surgeon may wish to avoid this region andconnect the proximal end of the graft vessel to any other adjacent lessdiseased vessel, such as the arteries leading to the arms or head.Further, the devices can be used with venous grafts, such as a harvestedsaphenous vein graft, arterial grafts, such as a dissected mammaryartery, or a synthetic prosthesis, as required.

Connection of the large vessel device does not require the stoppage ofblood flow in the target vessel. Moreover, the anastomotic devices canbe connected to the target vessel without the use of cardiopulmonarybypass. In contrast, anastomosis techniques wherein the aorta is clampedto interrupt blood flow to the area of the aortic wall to which a veinis to be anastomosed may result in liberation of plaques and tissuefragments which can lead to organ dysfunction, such as strokes, renalfailure, or intestinal ischemia. However, severely diseased aortas maynot provide an area suitable for clamping due to significantcalcification of the aortic wall. In the anastomosis technique accordingto the invention, the surgeon does not need significant room inside thepatient to connect the anastomotic devices to the target vessel. Forexample, unlike sutured anastomoses which require significant access tothe aorta for the surgeon to suture the graft vessel thereto, theanastomotic devices allow the proximal end of the graft vessel to beconnected to any part of the aorta. All parts of the aorta areaccessible to the large vessel anastomosis devices, even when minimallyinvasive procedures are used. Consequently, the graft vessel may beconnected to the descending aorta, so that the graft vessel would not bethreatened by damage during a conventional sternotomy if a secondoperation is required at a later time.

According to the invention, a sutureless connection can be providedbetween a graft and a target vessel, while minimizing thrombosis orrestenosis associated with the anastomosis. The anastomotic devices canbe attached to the target vessel inside a patient remotely from outsidethe patient using specially designed applicators, so that the devicesare particularly suitable for use in minimally invasive surgicalprocedures where access to the anastomosis site is limited. The devicesallow the anastomosis to be performed very rapidly, with highreproducibility and reliability, without clamping, and with or withoutthe use of cardiopulmonary bypass.

According to one preferred method of deploying the anastomosis device,the surgeon operates a deployment tool using both hands. One handsupports the tool via a handle while the other twists an actuation knobto deploy the anastomotic device. Locating the actuation knob on thetool's main axis minimizes the tendency of reaction forces to wobble thetool keeping it stable and in proper position during deployment. Thetwisting motion is converted to linear displacements by a set ofrotating cams that engage a trocar, holder, and expander. The camscontrol the sequence of relative motions between the instrument's trocarand device deployment mechanisms.

During the foregoing procedure, a surgeon will place the tip of theinstrument (the mechanical stop) in light contact with the site on theaorta to be anastomosed. Having located a suitable site, the surgeonthen twists the actuation knob to fire the spring-loaded trocar andcontinues twisting to deploy the anastomotic device. The trocarpenetrates the aortic wall at a high rate of speed to minimize anyunintended deformation of the aorta and maintains a substantiallyfluid-tight seal at the puncture site. Having entered the aortic lumen,the trocar dilates as the anastomotic device and its holder tube (crown)are advanced through it, thus retracting the aortic tissue and servingas an introducer for the device. Once the device has fully entered theaortic lumen the trocar is withdrawn. The anastomotic device is thenexpanded to its full diameter and an inner flange is deployed. Thedevice is then drawn outwards towards the instrument (mechanical stop)to seat the inner flange firmly against the intimal wall of the aorta.An outer flange is then deployed from the external side, compressing theaortic wall between the inner and outer flanges and the device isdisengaged from the instrument completing the anastomosis.

FIG. 1 illustrates the distal portion of an anastomosis device 10according to a first embodiment of the present invention, the proximalportion (not shown) being adapted to be deployed by a deployment toolwhich will be explained later. The anastomosis device 10 includes aplurality of axial members 12 and a plurality of struts 14interconnecting the axial members. The axial members 12 and struts 14form a first linkage 16 at a first end of the device and a secondlinkage 18 at a second end of the device. The first and second linkages16, 18 form inner and outer flanges 20, 22 when the anastomosis device10 is deployed as illustrated in FIG. 2. The deployed flanges 20, 22 maybe annular ring shaped or conical in shape. The first and secondlinkages 16, 18 are connected by a central connecting portion 24.

In use, a graft vessel 30 is inserted through a center of the tubularanastomosis device 10 and is everted over the first linkage 16 at thefirst end of the device. The first end of the device may puncture partway or all the way through the graft vessel wall to hold the graftvessel 30 on the device. An opening 34 is formed in the target vessel 32to receive the graft vessel 30 and anastomosis device 10. Once theanastomosis device 10 with everted graft vessel 30 are inserted throughthe opening 34 in the target vessel 32, the inner and outer flanges 20,22 are formed as shown in FIG. 2 to secure the graft vessel to thetarget vessel by trapping the wall of the target vessel between the twoflanges. The anastomosis device 10 forms a smooth transition between thetarget vessel 32 and the graft vessel 30 which helps to prevent thrombiformation.

The inner and outer flanges 20, 22 are formed by radial expansion of theanastomosis device 10 as follows. The first and second linkages 16, 18are each made up of a plurality of axial members 12 and struts 14. Thestruts 14 are arranged in a plurality of diamond shapes with adjacentdiamond shapes connected to each other to form a continuous ring ofdiamond shapes around the device. One axial member 12 extends through acenter of each of the diamond shapes formed by the struts 14. A reducedthickness section 26 or hinge in each of the axial members 12 provides alocation for concentration of bending of the axial members. When anexpansion member of a deployment tool such as a rod or balloon isinserted into the tubular anastomosis device 10 and used to radiallyexpand the device, each of the diamond shaped linkages of struts 14 areelongated in a circumferential direction causing a top and bottom ofeach of the diamond shapes to move closer together. As the top andbottom of the diamond shapes move closer together, the axial members 12bend along the reduced thickness sections 26 folding the ends of thedevice outward to form the inner and outer flanges 20, 22 with theresult that the wall of the target vessel 32 is trapped between theflanges and the everted graft vessel 30 is secured to the target vessel.

In the anastomosis device 10 shown in FIGS. 1 and 2, the struts 14 maybe straight or curved members having constant or varying thicknesses. Inaddition, the axial members 12 may have the reduced thickness sections26 positioned at a center of each of the diamond shapes or off centerinside the diamond shapes. The positioning and size of the reducedthickness sections 26 will determine the location of the flanges 20, 22and an angle the flanges make with an axis of the device when fullydeployed. A final angle between the flanges 20, 22 and longitudinal axisof the device 10 is about 40-100 degrees, preferably about 50-90degrees.

FIGS. 3-7 illustrate a deployment system 150 and sequence of deployingan anastomosis device 120 such as the device shown in FIGS. 1-2 with thedeployment system. In FIGS. 3-5 the graft vessel 30 has been eliminatedfor purposes of clarity. As shown in FIGS. 3-7, the deployment system150 includes a hollow outer trocar 152 (not shown in FIG. 3), a holdertube 154 positioned inside the trocar, and an expander tube 156 slidableinside the holder tube. As can be seen in the detail of FIG. 4, theanastomosis device 120 is attached to a distal end of the holder tube154 by inserting T-shaped ends 112 of pull tabs 110 in slots 158 aroundthe circumference of the holder tube. The trocar 152, holder tube 154,and expander tube 156 are all slidable with respect to one anotherduring operation of the device. A device handle 160 is provided formoving the tubes with respect to one another will be described infurther detail below with respect to FIGS. 8-11.

As shown in FIG. 5, initially, the holder tube 154, expander tube 156,and the anastomosis device 120 are positioned within the trocar 152 forinsertion. The trocar 152 has a hollow generally conical tip with aplurality of axial slots 162 which allow the conical tip to be spreadapart so that the anastomosis device 120 can slide through the openedtrocar. The trocar 152, acting as a tissue retractor and guide, isinserted through the wall of the target vessel 32 forming an opening 34.As shown in FIG. 6, the anastomosis device 120 is then advanced into orthrough the target vessel wall 32 with the holder tube 154. Theadvancing of the holder tube 154 causes the distal end of the trocar 152to be forced to spread apart. Once the anastomosis device 120 is inposition and the trocar 152 has been withdrawn, the inner annular flange20 is deployed by advancing the expander tube 156 into the anastomosisdevice. The advancing of the expander tube 156 increases the diameter ofthe anastomosis device 120 causing the inner flange to fold outward fromthe device. This expanding of the inner flange may be performed insidethe vessel and then the device 120 may be drawn back until the innerflange abuts an interior of the target vessel wall 32.

As shown in FIG. 8, after the inner flange has been deployed, the holdertube 154 is advanced forming the outer flange. As the holder tube 154 isadvanced, the anastomosis device 120 drops into a radial groove 157 onan exterior of the expander tube 156 which holds the anastomosis devicestationary on the expander tube 156. The holder tube 154 is then movedforward to detach the entire anastomosis device by disengaging the pulltabs 130 from the slots 158 in the holder tube and causing the outerflange to be deployed. During deployment of the outer flange, shoulders134 on the device, shown most clearly in FIGS. 5 and 6, engage a tapereddistal end of the holder tube 154 causing the pull tabs 130 to bereleased from the slots 158. Alternatively, and as will be explained inconnection with a frangible anastomosis device according to theinvention, movement of the holder tube 154 can detach a deployed portionof the device from a discard portion of the device which remainsattached to the holder tube.

One alternative embodiment of the holder tube 154 employs a plurality offlexible fingers which receive the pull tabs 130 of the anastomosisdevice 120. According to this embodiment each pull tab 130 is receivedby an independent finger of the holder tube 154. To deploy the second orouter flange of the anastomosis device 120, the flexible fingers flexoutward bending the pull tabs 130 outward. For instance, the flexiblefingers can be designed to flex when the pull tabs and fingers are putunder axial compression in which case the fingers and tabs buckleoutwards together to deploy the outer flange and release the anastomosisdevice from the holder tube.

FIGS. 9-12 illustrate the operation of the handle 160 to move the trocar152, the holder tube 154, and the expander tube 156 with respect to oneanother to deploy the anastomosis device 120 according to the presentinvention. The handle 160 includes a grip 170 and a trigger 172pivotally mounted to the grip at a pivot 174. The trigger 172 includes afinger loop 176 and three contoured cam slots 178, 180, 182corresponding to the trocar 152, holder tube 154, and expander tube 156,respectively. Each of these tubes has a fitting 184 at a distal endthereof. A pin 186 connected to each of the fittings 184 slides in acorresponding one of the cam slots 178, 180, 182. A fourth cam slot andtube may be added to control deployment of the outer flange.Alternatively, the handle can be modified to include fewer cam slots fordeployment of the inner and outer flanges.

The handle 160 is shown in FIG. 8 in an insertion position in which thetrocar 152 extends beyond the holder tube 154 and the expander tube 156for puncturing of the target vessel wall 32. Optionally, a flexible seal(not shown) such as heat shrinkable plastic or elastomeric tubing can beprovided on the outer surface of the trocar 152 such that the sealcovers the axial slots 162 at a location spaced from the tip of thetrocar to prevent leaking of blood from the target vessel after theincision is formed. In a preferred embodiment, the trocar is actuated bya mechanism which causes the trocar to penetrate the aorta wall at ahigh rate of speed to minimize deformation of the aorta and maintain afluid tight seal at the puncture site in a manner similar to biopsy gun.For instance, the spring mechanism attached to the trocar and/or thehandle can be used to fire the trocar at the incision site. Any suitableactuating mechanism can be used to fire the trocar in accordance withthe invention. As the trigger 172 is rotated from the positionillustrated in FIG. 9 to the successive positions illustrated in FIGS.10-12, the pins 186 slide in the cam slots 178, 180, 182 to move thetrocar 152, holder tube 154 and expander tube 156.

FIG. 10 shows the handle 160 with the trigger 172 rotated approximately30 degrees from the position of FIG. 9. This rotation moves the holdertube 154 and expander tube 156 forward into the wall of the targetvessel 32 spreading the trocar 152. The anastomosis device 120 is now inposition for deployment. FIG. 11 shows the trigger 172 rotatedapproximately 45 degrees with respect to the position of FIG. 9 and thecam slot 182 has caused the expander tube 156 to be advanced within theholder tube 154 to deploy the inner flange. The trocar 152 has also beenwithdrawn.

FIG. 12 shows the handle 160 with the trigger 172 pivoted approximately60 degrees with respect to the position shown in FIG. 9. As shown inFIG. 12, the expander tube 156 has been withdrawn to pull the innerflange against the vessel wall 32 and the holder tube 154 is movedforward to deploy the outer flange and disengage the holder tube 154from the anastomosis device 120.

The handle 160 also includes a first channel 188 and a second channel190 in the grip 170 through which the graft vessel (not shown) may beguided. The grip 170 also includes a cavity 192 for protecting anopposite end of the graft vessel from the attachment end.

According to one embodiment of the invention, the anastomosis deviceincludes a frangible linkage which allows an implant to separate fromthe remainder of the device upon formation of the outer flange.According to a preferred linkage design, the frangible linkage can beradially expanded and axially compressed to fracture the frangiblelinkage. The inner flange can be formed during radial expansion of thedevice and the implant can be severed while forming the outer flange.

FIG. 13 shows a device 200 which cooperates with a deployment tool 300for delivering and deploying an implant 204 at a site in a living body.The device includes a frangible linkage 202 connecting the implant 204to a discard portion 206. As explained below, after the device ispositioned at a desired location, the implant 204 can be expanded todeploy an inner flange and subsequently axially compressed to deploy anouter flange while severing the implant 204 from the discard portion206. The deployment tool can then be withdrawn along with the discardportion 206 which remains attached to the distal end of the deploymenttool 300.

FIG. 14 shows the device 200 in the radially expanded condition butprior to being axially compressed. During radial expansion of thedevice, axially extending barbs 208 (FIG. 13) are pivoted outwardly bystruts 210 such that the outwardly extending barbs 208 and struts 210form the inner flange. To facilitate bending of the barbs, the barbs 208comprise points on the ends of axially extending members 212 which havenarrow sections 214 located a desired distance from the free ends of thebarbs 208. For instance, the narrow sections 214 can be located at axialpositions along the device corresponding approximately to the axialmidpoint of the struts 210 connecting adjacent members 212 when thedevice is in the pre-expanded condition shown in FIG. 13.

To facilitate easier bending of the struts 210 during radial expansionof the device, the distal ends of the struts can be curved at theirpoints of attachment to the members 212. Likewise, a curved bend can beprovided at the intersection where the proximal ends of the struts areattached together. When the device is radially expanded, the members 212move radially outward and circumferentially apart as the struts 210 moveradially outward until a force on the barbs 208 by the struts 210 causesthe struts to become bent at the narrow sections 214, after which thebarbs extend outwardly to form the inner flange. In this deployedcondition, the barbs 208 are locked into position by an X-shaped frameformed by struts 210 and additional struts 216. The struts 216 aresimilar in configuration to the struts 210 with respect to how they areshaped and attached to the members 212. Short axially extending members218 connect the intersection of the struts 210 to the intersection ofthe struts 216.

The frangible section 202 is located at the proximal ends of axiallyextending members 220 which are connected to the members 212 by U-shapedlinks 222. The members 220 are arranged in pairs which are attachedtogether at only their distal ends. In particular, the distal ends ofthe links 222 are attached to proximal ends of the members 212 and themidpoint of each link 222 is attached to the distal ends of a respectivepair of members 220. As shown in FIG. 14, during radial expansion of thedevice, the individual links 222 are plastically deformed from theirU-shaped configuration to form segments of a circumferentially extendingannular ring. As a result, the device becomes shorter in the axialdirection as links 222 form the annular ring and the distal ends of themembers 220 move radially outward but not apart in the circumferentialdirection. At the same time, the proximal ends of the members 220 moveradially outward and circumferentially apart.

FIG. 15 shows an expanded view of the circled portion A in FIG. 14 andFIG. 16 shows how the frangible section 202 can be bent to fractureconnection points between members 220 and axial extending members 224.As shown in FIGS. 14 and 15, proximal ends of the members 224 areattached to U-shaped links 226 which allow the proximal ends of themembers 224 to move radially outward but not circumferentially apartwhen the device is expanded. As shown in FIG. 15, the distal ends ofmembers 224 and connected to the proximal ends of the members 220 by afrangible joint comprised of shearable connections 228. In theembodiment shown, the members 220 are connected at their proximal endsby a cross piece 230 and the members 224 are connected at their distalends by a cross piece 232. The cross piece 230 includes a recess 234 andthe cross piece 232 includes a projection 236 located in the recess 234.The frangible joint is preferably formed from a unitary piece ofmaterial (e.g., stainless steel, nickel titanium alloy, etc.) such as alaser cut tube wherein the shearable connections 228 comprise thinsections of material extending between opposite sides of the projection236 and opposing walls of the recess 234. As shown in FIG. 16, therecess 234 contains the projection 236 as the members 220 and 224 arepivoted about the joint formed by the shearable connections 228. Whenthe members 220 and 224 are pivoted to a sufficient extent, theshearable connections 228 are fractured allowing the implant to separatefrom the discard portion of the device.

The frangible link shown in FIGS. 15-16 can be modified in various ways.For instance, as shown in FIG. 17, the projection can have a slot 238extending from the free end thereof towards cross piece 232. The slot238 allows the portions of the projection on either side of the slot 238to move closer together as the proximal ends of members 224 bend awayfrom each other during radial expansion of the device 200. Likewise, theproximal ends of the members 220 on either side of the projection 236can move closer together as the distal ends of the members 220 moveapart during the radial expansion. Another variation is shown in FIG. 18wherein two projections 236 a and 236 b extend from cross piece 232 andtwo projections 236 c and 236 d extend from cross piece 230, projections236 a and 236 d being connected by a first shearable connection 228 andprojections 236 c and 236 d being connected by a second shearableconnection 228. As with the arrangement in FIG. 17, the arrangement inFIG. 18 allows the projections 236 a-d to become squeezed togetherduring radial expansion of the device 200.

The device 200 can be deployed using deployment tool 300 as follows. Asshown in FIGS. 13 and 14, the device 200 includes a crown 240 attachedto a distal end 302 of the tool 300. The crown includes axiallyextending members 242 with tabs (not shown) on the proximal endsthereof, the members 242 being held in slots 304 of the tool 300 by thetabs. A plastic sleeve (not shown) can be placed over the slots 304 toprevent the members 242 from coming out of the slots. As shown in FIG.13, the crown is flared outwardly such that the members 242 are fullyradially expanded at their proximal ends. During radial expansion of thedevice 200, the diamond shaped linkage of the crown 240 is expanded fromthe configuration shown in FIG. 13 to the expanded configuration shownin FIG. 14.

In the embodiment shown in FIGS. 13-14, the device 200 is attached tothe tool 300 in a manner such that the discard portion 206 stays withthe tool during deployment of the implant 204 and removal of the toolfrom the implant site. As previously described, the discard can includetabbed members fitted in grooves of the tool. Other suitable attachmenttechniques include welding the proximal end of the device to the toolusing resistance welding, ultrasonic welding or the like, molding theproximal end of the device into the distal end of the tool such as byinsert molding, mechanically fastening the proximal end of the device tothe tool, adhesive bonding, etc.

In the foregoing embodiment, the device is deployed by radial expansionand axial compression. The axial compression can be accomplished bypushing the holder tube while the expander tube is held in a fixedposition or vice versa. According to a further embodiment, the axialcompression can be accomplished by rotation of the device. For instance,FIG. 19, showing a buckling crown 240 a which includes helical members244 extending from a ring 246 attached to the distal end 302 of the tool300. Additional helical members 248 which form the outer flange of theimplant are connected to the helical members 244 by shearableconnections 250. During deployment of the outer flange, the tool 300 isrotated while preventing the implant 204 from rotating with the resultthat the helical members 244 and 248 bend outwardly at the location ofthe shearable connections 250 and form the outer flange. After formationof the outer flange, the shearable connections 250 fracture releasingthe implant 204 from the crown 240 a which remains attached to the tool.As with the previously described device, the crown 240 a can be attachedto the tool in any desired manner, e.g. welding, molding, etc.

According to the next embodiment, the device can be designed so as to bereleased from the tool without use of fracture elements. For example,the tool can include a deforming crown which mechanically disengageswith the device after forming the outer flange. The device and tool canincorporate any suitable release mechanism which, for example, connectsthe crown to the deployment tool when a tensile force is applied to theconnection but which disconnects when a compressive force is applied tothe connection, e.g., hooks, tabs, spring clips, etc. FIG. 20 shows anembodiment of a tool with a deforming crown 306 comprised of struts 308and tabs 310 connected to the struts 308 by thin necks 312. The device200 a is similar to device 200 except that device 200 a does not includefrangible links. Instead, device 200 a includes bendable members 252which are bent outwardly by the deforming crown 306 to form the outerflange. As shown in FIG. 21, each of the members 252 includes a hole 254sized larger than the tabs to allow the tabs to be released from theholes after the outer flange is formed. When the device 200 a isattached to the tool 300, the tabs 310 are fitted in the holes with thenecks 312 received in the slots 256. The struts 308 can be shorter thanthe members 252 so that when the outer flange is formed the members 252extend outwardly further than the struts 308. As a result, the necks 312slide out of the slots 256 and the tabs 310 slide out of the holes 254as the outer flange is formed and the implant is released from the tool.

FIG. 22 shows a device 400 (illustrated in planar form for ease ofdescription but which would be used in a tubular shape) which cooperateswith a deployment tool (as described earlier) for delivering anddeploying an implant 404 at a site in a living body. The device includesa frangible linkage 402 connecting the implant 404 to a discard portion406. As explained with reference to the embodiment shown in FIGS. 13-14,after the device is positioned at a desired location, the implant 404can be expanded to deploy an inner flange and subsequently axiallycompressed to deploy an outer flange while severing the implant 404 fromthe discard portion 406. The deployment tool can then be withdrawn alongwith the discard portion 406 which remains attached to the distal end ofthe deployment tool.

During radial expansion of the device, axially extending barbs 408 arepivoted outwardly by struts 410 such that the outwardly extending barbs408 and struts 410 form the inner flange. To facilitate bending of thebarbs, the barbs 408 comprise points on the ends of axially extendingmembers 412 which have narrow sections 414 located a desired distancefrom the free ends of the barbs 408. For instance, the narrow sections414 can be located at axial positions along the device correspondingapproximately to the axial midpoint of the struts 410 connectingadjacent members 412 when the device is in the pre-expanded condition.

To facilitate easier bending of the struts 410 during radial expansionof the device, the distal ends of the struts can be curved at theirpoints of attachment to the members 412. Likewise, a curved bend can beprovided at the intersection where the proximal ends of the struts areattached together. When the device is radially expanded, the members 412move radially outward and circumferentially apart as the struts 410 moveradially outward until a force on the barbs 408 by the struts 410 causesthe struts to become bent at the narrow sections 414, after which thebarbs extend outwardly to form the inner flange. In this deployedcondition, the barbs 408 are locked into position by an X-shaped frameformed by struts 410 and additional struts 416. The struts 416 aresimilar in configuration to the struts 410 with respect to how they areshaped and attached to the members 412. Short axially extending members418 connect the intersection of the struts 410 to the intersection ofthe struts 416.

The frangible section 402 is located at the proximal ends of axiallyextending members 420 which are connected to the members 412 by U-shapedlinks 422. The members 420 are arranged in pairs which are attachedtogether at midpoints of links 422. During radial expansion of thedevice, the individual links 422 are plastically deformed from theirU-shaped configuration to form segments of a circumferentially extendingannular ring. As a result, the device becomes shorter in the axialdirection as links 422 form the annular ring and the distal ends of thepairs of members 420 attached to an individual link 422 move radiallyoutward but not apart in the circumferential direction. At the sametime, the proximal ends of the members 420 move radially outward andcircumferentially apart.

The frangible section 402 is located between axial members 420 andaxially extending members 424. As shown in FIG. 22, the members 420 arecloser together at their distal ends and this condition remains afterexpansion of the device. The proximal ends of the members 424 areattached to mid-points of U-shaped links 426 by a pair of short andclosely spaced apart axially extending links 427. The distal ends ofmembers 424 are connected to the proximal ends of the members 420 by afrangible joint comprised of shearable connections 402 which operate ina manner similar to the previously discussed connections 228, i.e., asshown in FIG. 23, the members 420 are connected at their proximal endsby a cross piece 430 and the members 424 include a projection 436received in a recess 434. The frangible joint is formed from a unitarypiece of material such as a laser cut tube wherein the shearableconnections 402 comprise thin sections of material extending betweenopposite sides of the projection 436 and opposing walls of the recess434. When the members 420 and 424 are pivoted to a sufficient extent,the shearable connections 402 are fractured allowing the implant toseparate from the discard portion of the device.

The device 400 can be deployed in the same manner that the device 200 isdeployed using deployment tool 300. That is, the device 400 includes acrown attached to a distal end of the deployment tool. The crownincludes axially extending members 442 with tabs 443 on the proximalends thereof, the members 442 being held in slots 304 of the tool 300 bythe tabs 443. A plastic sleeve (not shown) can be placed over the slots304 to prevent the members 442 from coming out of the slots. Whenmounted on the deployment tool, the crown is flared outwardly such thatthe members 442 are fully radially expanded at their proximal ends.During radial expansion of the device 400, the diamond shaped linkage ofthe crown 440 is expanded from an unexpanded condition like theconfiguration shown in FIG. 13 to an expanded condition like theexpanded configuration shown in FIG. 14.

FIG. 24 shows a device 500 (illustrated in planar form for ease ofdescription but which would be used in a tubular shape) which cooperateswith a deployment tool (as described earlier) for delivering anddeploying an implant 504 at a site in a living body. The device includesa frangible linkage 502 connecting the implant 504 to a discard portion506. As explained with reference to the embodiment shown in FIGS. 13-14,after the device is positioned at a desired location, the implant 504can be expanded to deploy an inner flange and subsequently axiallycompressed to deploy an outer flange while severing the implant 504 fromthe discard portion 506. The deployment tool can then be withdrawn alongwith the discard portion 506 which remains attached to the distal end ofthe deployment tool.

During radial expansion of the device, axially extending barbs 508 arepivoted outwardly by struts 510 such that the outwardly extending barbs508 and struts 510 form the inner flange. To facilitate bending of thebarbs, the barbs 508 comprise points on the ends of axially extendingmembers 512 which have narrow sections 514 located a desired distancefrom the free ends of the barbs 508. For instance, the narrow sections514 can be located at axial positions along the device correspondingapproximately to the axial midpoint of the struts 510 connectingadjacent members 512 when the device is in the pre-expanded condition.

To facilitate easier bending of the struts 510 during radial expansionof the device, the distal ends of the struts can be curved at theirpoints of attachment to the members 512. Likewise, a curved bend can beprovided at the intersection where the proximal ends of the struts areattached together. When the device is radially expanded, the members 512move radially outward and circumferentially apart as the struts 510 moveradially outward until a force on the barbs 508 by the struts 510 causesthe struts to become bent at the narrow sections 514, after which thebarbs extend outwardly to form the inner flange. In this deployedcondition, the barbs 508 are locked into position by an X-shaped frameformed by struts 510 and additional struts 516. The struts 516 aresimilar in configuration to the struts 510 with respect to how they areshaped and attached to the members 512. Short axially extending members518 connect the intersection of the struts 510 to the intersection ofthe struts 516.

The frangible section 502 is located at the proximal ends of axiallyextending members 520 which are connected to the members 512 by U-shapedlinks 522. The members 520 are arranged in pairs which are attachedtogether at only their distal ends. In particular, the distal ends ofthe links 522 are attached to proximal ends of the members 512 and themidpoint of each link 522 is attached to the distal ends of a respectivepair of members 520. During radial expansion of the device, theindividual links 522 are plastically deformed from their U-shapedconfiguration to form segments of a circumferentially extending annularring. As a result, the device becomes shorter in the axial direction aslinks 522 form the annular ring and the distal ends of the members 520move radially outward but not apart in the circumferential direction. Atthe same time, the proximal ends of the members 520 move radiallyoutward and circumferentially apart.

The frangible section 502 is located between pairs of the axial members520 and pairs of axially extending members 524. As shown in FIG. 24,each pair of members 520 attached to an individual link 522 are closertogether at their distal ends and this condition remains when the deviceis expanded. The proximal ends of pairs of the members 524 are attachedat locations intermediate mid-points and ends of U-shaped links 526 by apair of curved links 527. During expansion of the device, the U-shapedlinks 526 deform into a circumferentially extending ring and cause theproximal ends of the members 524 to spread apart such that a gap 528between the members 524 becomes wider at the proximal ends of themembers 524. To aid spreading of the members 524, the members include acurved recess 529 at the distal ends thereof. The distal ends of members524 are connected to the proximal ends of the members 520 by a frangiblejoint comprised of shearable connections 502 which operate in a mannersimilar to the previously discussed connections 228, i.e., as shown inFIG. 25, the members 520 are connected at their proximal ends by a crosspiece 530 and the members 524 are connected by a cross piece 535 whichincludes a projection 536 received in a recess 534. The frangible jointis formed from a unitary piece of material such as a laser cut tubewherein the shearable connections 502 comprise thin sections of materialextending between opposite sides of the projection 536 and opposingwalls of the recess 534. When the members 520 and 524 are pivoted to asufficient extent, the shearable connections 502 are fractured allowingthe implant to separate from the discard portion of the device.

The device 500 can be deployed in the same manner that the device 200 isdeployed using deployment tool 300. That is, the device 500 includes acrown attached to a distal end of the deployment tool. The crownincludes axially extending members 542 with tabs 543 on the proximalends thereof, the members 542 being held in slots 304 of the tool 300 bythe tabs 543. A plastic sleeve (not shown) can be placed over the slots304 to prevent the members 542 from coming out of the slots. Whenmounted on the deployment tool, the crown is flared outwardly such thatthe members 542 are fully radially expanded at their proximal ends.During radial expansion of the device 500, the diamond shaped linkage ofthe crown 540 is expanded from an unexpanded condition like theconfiguration shown in FIG. 13 to an expanded condition like theexpanded configuration shown in FIG. 14.

FIG. 26 shows a device 600 (illustrated in planar form for ease ofdescription but which would be used in a tubular shape) which cooperateswith a deployment tool (as described earlier) for delivering anddeploying an implant 604 at a site in a living body. The device includesa frangible linkage 602 connecting the implant 604 to a discard portion606. As explained with reference to the embodiment shown in FIGS. 13-14,after the device is positioned at a desired location, the implant 604can be expanded to deploy an inner flange and subsequently axiallycompressed to deploy an outer flange while severing the implant 604 fromthe discard portion 606. The deployment tool can then be withdrawn alongwith the discard portion 606 which remains attached to the distal end ofthe deployment tool.

During radial expansion of the device, axially extending barbs 608 arepivoted outwardly by struts 610 such that the outwardly extending barbs608 and struts 610 form the inner flange. To facilitate bending of thebarbs, the barbs 608 comprise points on the ends of axially extendingmembers 612 which have narrow sections 614 located a desired distancefrom the free ends of the barbs 608. For instance, the narrow sections614 can be located at axial positions along the device correspondingapproximately to a position slightly distal of the axial midpoint of thestruts 610 connecting adjacent members 612 when the device is in thepre-expanded condition.

To facilitate easier bending of the struts 610 during radial expansionof the device, the distal ends of the struts can be curved at theirpoints of attachment to the members 612. Likewise, a curved bend can beprovided at the intersection where the proximal ends of the struts areattached together. When the device is radially expanded, the members 612move radially outward and circumferentially apart as the struts 610 moveradially outward until a force on the barbs 608 by the struts 610 causesthe struts to become bent at the narrow sections 614, after which thebarbs extend outwardly to form the inner flange. In this deployedcondition, the barbs 608 are locked into position by an X-shaped frameformed by struts 610 and additional struts 616. The struts 616 aresimilar in configuration to the struts 610 with respect to how they areshaped and attached to the members 612. Short axially extending members618 connect the intersection of the struts 610 to the intersection ofthe struts 616.

The frangible section 602 is located at the proximal ends of axiallyextending members 620 which are connected to the members 612 by U-shapedlinks 622. The members 620 are arranged as circumferentially spacedapart pairs which are attached together at midpoints of links 622.During radial expansion of the device, the individual links 622 areplastically deformed from their U-shaped configuration to form segmentsof a circumferentially extending annular ring. As a result, the devicebecomes shorter in the axial direction as links 622 form the annularring. At the same time, the proximal ends of each pair of members 620attached to an individual link 622 move radially outward and apart inthe circumferential direction.

The frangible section 602 is located between pairs of the axial members620 and pairs of axially extending members 624. As shown in FIG. 26, themembers 620 are substantially parallel to each other when the device isin its unexpanded condition, i.e., prior to formation of the innerflange. However, when the device is radially expanded the distal ends ofthe members 620 will remain closer together than their proximal endssince the distal ends are attached to a midpoint of the links 622. Theproximal ends of pairs of the members 624 are attached at mid-points ofU-shaped links 626 by a pair of thin links 627. During expansion of thedevice, the U-shaped links 626 deform into a circumferentially extendingring while proximal ends of pairs of the members 624 spread apart suchthat a gap 628 between the pairs of members 624 becomes wider at theproximal ends of the members 624. To aid spreading of the pairs ofmembers 624, the members 624 include a curved recess 629 at the distalends thereof. The distal ends of members 624 are connected to theproximal ends of the members 620 by a frangible joint comprised ofshearable connections 602 which operate in a manner similar to thepreviously discussed connections 228, i.e., as shown in FIG. 27, themembers 620 are connected at their proximal ends by a cross piece 630and the members 624 are connected by a cross piece 635 which includes aprojection 636 received in a recess 634. The frangible joint is formedfrom a unitary piece of material such as a laser cut tube wherein theshearable connections 602 comprise thin sections of material extendingbetween opposite sides of the projection 636 and opposing walls of therecess 634. When the members 620 and 624 are pivoted to a sufficientextent, the shearable connections 602 are fractured allowing the implantto separate from the discard portion of the device.

The device 600 can be deployed in the same manner that the device 200 isdeployed using deployment tool 300. That is, the device 600 includes acrown attached to a distal end of the deployment tool. The crownincludes axially extending members 642 with tabs 643 on the proximalends thereof, the members 642 being held in slots 304 of the tool 300 bythe tabs 643. A plastic sleeve (not shown) can be placed over the slots304 to prevent the members 642 from coming out of the slots. Whenmounted on the deployment tool, the crown is flared outwardly such thatthe members 642 are fully radially expanded at their proximal ends.During radial expansion of the device 600, the diamond shaped linkage ofthe crown 640 is expanded from an unexpanded condition like theconfiguration shown in FIG. 13 to an expanded condition like theexpanded configuration shown in FIG. 14.

FIG. 24 shows a device 700 (illustrated in planar form for ease ofdescription but which would be used in a tubular shape) which cooperateswith a deployment tool (as described earlier) for delivering anddeploying an implant 704 at a site in a living body. The device includesa frangible linkage 702 connecting the implant 704 to a discard portion706. As explained with reference to the embodiment shown in FIGS. 13-14,after the device is positioned at a desired location, the implant 704can be expanded to deploy an inner flange and subsequently axiallycompressed to deploy an outer flange while severing the implant 704 fromthe discard portion 706. The deployment tool can then be withdrawn alongwith the discard portion 706 which remains attached to the distal end ofthe deployment tool.

During radial expansion of the device, axially extending barbs 708 arepivoted outwardly by struts 710 such that the outwardly extending barbs708 and struts 710 form the inner flange. To facilitate bending of thebarbs, the barbs 708 comprise points on the ends of axially extendingmembers 712 which have narrow sections 714 located a desired distancefrom the free ends of the barbs 708. For instance, the narrow sections714 can be located at axial positions along the device correspondingapproximately to the axial midpoint of the struts 710 connectingadjacent members 712 when the device is in the pre-expanded condition.

To facilitate easier bending of the struts 710 during radial expansionof the device, the distal ends of the struts can be curved at theirpoints of attachment to the members 712. Likewise, a curved bend can beprovided at the intersection where the proximal ends of the struts areattached together. When the device is radially expanded, the members 712move radially outward and circumferentially apart as the struts 710 moveradially outward until a force on the barbs 708 by the struts 710 causesthe struts to become bent at the narrow sections 714, after which thebarbs extend outwardly to form the inner flange. In this deployedcondition, the barbs 708 are locked into position by an X-shaped frameformed by struts 710 and additional struts 716. The struts 716 aresimilar in configuration to the struts 710 with respect to how they areshaped and attached to the members 712. Short axially extending members718 connect the intersection of the struts 710 to the intersection ofthe struts 716.

The frangible section 702 is located at the proximal ends of axiallyextending members 720 which are connected to the members 712 by U-shapedlinks 722 and U-shaped links 723. The members 720 are arranged in pairswhich are attached at their distal ends to proximal ends of the links723 and the midpoints of the links 723 are attached to midpoints of thelinks 722. The ends of the links 722 are attached to the proximal endsof adjacent members 718. During radial expansion of the device, theindividual links 722, 723 are plastically deformed from their U-shapedconfiguration to form segments of two circumferentially extendingannular rings. As a result, the device becomes shorter in the axialdirection as links 722, 723 form the annular rings and the distal endsof each pair of the members 720 attached to an individual link 723 moveradially outward but not apart in the circumferential direction. At thesame time, the proximal ends of pairs of the members 720 move radiallyoutward and circumferentially apart.

The frangible section 702 is located between pairs of the axial members720 and pairs of axially extending members 724. As shown in FIG. 28, themembers 720 attached to an individual link 722 are somewhat closertogether at their distal ends than their proximal ends, a conditionwhich remains after expansion of the device. The proximal ends of pairsof the members 724 are attached to mid-points of U-shaped links 726 by apair of short links 727. During expansion of the device, the U-shapedlinks 726 deform into a circumferentially extending ring and cause theproximal ends of the members 724 to spread apart such that a gap 728between the members 724 becomes wider at the proximal ends of themembers 724. To aid spreading of the members 724, the members include acurved recess 729 at the distal ends thereof. The distal ends of members724 are connected to the proximal ends of the members 720 by a frangiblejoint comprised of shearable connections 702 which operate in a mannersimilar to the previously discussed connections 228, i.e., as shown inFIG. 29, the members 720 are connected at their proximal ends by a crosspiece 730 and the members 724 are connected by a cross piece 735 whichincludes a projection 736 received in a recess 734. The frangible jointis formed from a unitary piece of material such as a laser cut tubewherein the shearable connections 702 comprise thin sections of materialextending between opposite sides of the projection 736 and opposingwalls of the recess 734. When the members 720 and 724 are pivoted to asufficient extent, the shearable connections 702 are fractured allowingthe implant to separate from the discard portion of the device.

The device 700 can be deployed in the same manner that the device 200 isdeployed using deployment tool 300. That is, the device 700 includes acrown attached to a distal end of the deployment tool. The crownincludes axially extending members 742 with tabs 743 on the proximalends thereof, the members 742 being held in slots 304 of the tool 300 bythe tabs 743. A plastic sleeve (not shown) can be placed over the slots304 to prevent the members 742 from coming out of the slots. Whenmounted on the deployment tool, the crown is flared outwardly such thatthe members 742 are fully radially expanded at their proximal ends.During radial expansion of the device 700, the diamond shaped linkage ofthe crown 740 is expanded from an unexpanded condition like theconfiguration shown in FIG. 13 to an expanded condition like theexpanded configuration shown in FIG. 14.

FIGS. 30 and 31 show details of a tissue anchoring arrangement which canoptionally be incorporated in the anastomosis device according to theinvention. In particular, FIG. 30 shows a distal end of a device 800(illustrated in planar form for ease of description but which would beused in a tubular shape) wherein axially extending members 802 havingpoints 804 for penetrating the graft vessel (as described earlier) alsoinclude a tissue anchoring arrangement 806. The tissue anchoringarrangement 806 comprises one or more projections (e.g., tangs or barbs)extending from one or both sides of the members 802, the projectionsproviding anchor points against the inner surface 810 of the targetvessel 812, as shown in FIG. 31 (wherein illustration of the graftvessel has been omitted). The projections 806 can include points 808which embed themselves in the tissue of the target vessel with orwithout penetrating the tissue. It is desirable that the projectionsprovide enough of an anchoring effect to prevent sudden increases inblood pressure in the target vessel (after the anastomosis operation)from rupturing the seal between the graft vessel and the target vesselcreated by the anastomosis device. The outer flange can also includeanchoring projections which can be used in lieu of or addition toanchoring projections on the inner flange.

A preferred method of loading an expander 156 in a holder tube 154 andplacing a graft vessel over the anastomosis device is explained withreference to FIG. 32, wherein expander 156 has been inserted in holdertube 154. However, prior to insertion of the expander, the barbed ends824 of device 820 preferably are bent outwardly so as to form an anglesuch as 5 to 60° to the central axis of the device. Afterwards, theexpander 156 can be advanced within the holder tube 154 to a location atwhich a proximal portion 822 of anastomosis device 820 is expanded overthe expander. As a result of contact of the beveled end of the expander156 with axial members 826, the barbed ends 824 can be rotated inwardlysomewhat to form a smaller angle with the central axis of the device820. Then, after a graft vessel is threaded through the anastomosisdevice 820, the end of the graft vessel can be everted over the distalend of the anastomosis device and the barbed ends 824 can be pokedthrough the graft vessel. Details of how this eversion process can becarried out are set forth in commonly assigned U.S. patent. applicationSer. No. 09/440,116 filed on Nov. 15, 1999. With the anastomosis deviceand everted graft vessel in such a condition, the holder tube 154 can beloaded in a trocar (not shown). Details of preferred trocar designs andan explanation of how the trocar creates an incision in a target vesselcan be found in commonly assigned U.S. patent application Ser. No.09/440,263.

In order to deploy the device 820, the inner flange can be expanded bypushing the expander 156 a set distance while maintaining the holdertube 154 in a fixed position. As a result, the linkage of the innerflange rotates the barbed ends 824 about the hinged connections 828 suchthat the barbed ends 824 from an angle of 40 to 140° with the centralaxis. Then, the holder tube 154 is pushed a set distance while holdingthe expander 156 in a fixed position to deploy the outer flange. As aresult, the linkage of the outer flange and the discard portion of theanastomosis device is axially compressed such that the linkage fracturesas the outer flange is rotated outwardly and towards the alreadydeployed inner flange.

Each of the anastomosis devices described above are preferably singlepiece devices which are formed by laser cutting or punching from a tubeor sheet of material. The devices may be provided in varying sizes tojoin vessels such as arteries, veins, bile ducts, etc., of differentsizes. Although various linkage arrangements have been shown wherein thedevices include struts which extend between two circumferentially spacedapart locations and axial members which extend between two axiallyspaced apart locations, the linkages which form the flanges could alsobe formed by V-shaped links arranged in diamond like patterns. Forexample, FIG. 33 shows an example of a tubular mesh 830 which can beaxially compressed to form an outwardly extending flange. The mesh 830includes short links 832 and 838 and long links 834 and 836, the links832 and 834 being joined to form a first diamond shaped pattern, thelinks 834 and 836 being joined to form a second diamond shaped pattern,and the links 836 and 838 being joined to form a third diamond shapedpattern. With such an arrangement, axial compression of the tubular mesh830 will cause the links 834 and 836 to pivot about joints 835connecting the links 834 to the links 836 and thus form a flange asillustrated in FIG. 34.

The mesh 830 can be joined to another mesh with the same or differentlinkage arrangement with or without a connecting linkage therebetween.If the same linkage arrangement is used, in order to obtain deploymentof one flange prior to deployment of the other flange, one of thelinkages can be made with wider and/or thicker links. For example, byusing a distal linkage of thin links and a proximal linkage of thicklinks, it is possible to deploy the inner flange prior to deployment ofthe outer flange. In other words, axial compression of the tubular meshcan cause the weaker distal linkage to deploy first and form the innerflange after which the outer flange can be formed by axial compressionof the stronger proximal linkage.

Although the invention has been principally discussed with respect tocoronary bypass surgery, the anastomosis devices of the presentinvention may be used in other types of anastomosis procedures. Forexample, the anastomosis device may be used in femoral-femoral bypass,vascular shunts, subclavian-carotid bypass, organ transplants, and thelike.

The anastomosis devices may be made of any known material which can bebent and will retain the bent shape such as stainless steel, nickeltitanium alloys, and the like. The hinges or pivot joints which havebeen discussed above in the various embodiments of the present inventionmay be designed to concentrate the bending at a desired location.

While the invention has been described in detail with reference to thepreferred embodiments thereof, it will be apparent to one skilled in theart that various changes and modifications can be made and equivalentsemployed, without departing from the present invention.

What is claimed is:
 1. An anastomosis device which cooperates with adeployment tool for connecting an end of a graft vessel to a targetvessel, the anastomosis device comprising: a first portion deformable bythe deployment tool to form a first flange; and a second portiondeformable by the deployment tool to form a second flange which togetherwith the first flange connects the graft vessel to the target vessel,the second portion including deformable members which cooperate with thedeployment tool to form the second flange, and wherein the deploymenttool further includes an expander which forms the first flange and aholder tube surrounding the expander, the holder tube includingelastically deformable members at the distal end thereof, theelastically deformable members engaging the deformable members andbending the deformable members outwardly during the step of forming thesecond flange.
 2. The anastomosis device of claim 1, wherein thedeformable members include first members and the elastically deformablemembers include second members which remain connected to the firstmembers during formation of the first flange and disconnect from thefirst members during formation of the second flange, the elasticallydeformable members returning to a non-bent configuration after formationof the second flange.
 3. An anastomosis device which cooperates with adeployment tool for connecting an end of a graft vessel to a targetvessel, the anastomosis device comprising: a first portion deformable bythe deployment tool to form a first flange; and a second portiondeformable by the deployment tool to form a second flange which togetherwith the first flange connects the graft vessel to the target vessel,the second portion including deformable links which cooperate with thedeployment tool to form the second flange, wherein the deployment toolincludes an expander which forms the first flange and a holder tubesurrounding the expander, the holder tube including deformable membersat the distal end thereof, the deformable members engaging thedeformable links and bending the deformable links outwardly during thestep of forming the second flange.
 4. The anastomosis device of claim 3,wherein the deformable links include first members and the deformablemembers include second members which remain connected to the firstmembers during formation of the first flange and disconnect from thefirst members during formation of the second flange, the deformablemembers remaining in a bent configuration after formation of the secondflange.
 5. The anastomosis device of claim 4, wherein the first memberscomprise tabs and the second members comprise slots which engage thetabs and openings which disengage the tabs, the slots extending from theopenings towards a proximal end of the anastomosis device.
 6. Ananastomosis device which cooperates with a deployment tool forconnecting an end of a graft vessel to a target vessel, the anastomosisdevice comprising: a first portion deformable by the deployment tool toform a first flange; and a second portion deformable by the deploymenttool to form a second flange which together with the first flangeconnects the graft vessel to the target vessel, the second portionincluding deformable members which cooperate with the deployment tool toform the second flange, wherein the anastomosis device includes adeployed portion and a severable portion, the first and second flangesbeing formed on the deployed portion and the severable portion beingseparated from the deployed portion when the second flange is formed. 7.The anastomosis device of claim 6, wherein the deployed portion isconnected to the severable portion by shearable connectors.
 8. Theanastomosis device of claim 7, wherein the shearable connectors arelocated at pivot connections between the deployed portion and theseverable portion, the severable portion and the deployed portion beingmachined from a single piece of metal and the pivot connectionscomprising thin sections of the metal extending between the deployedportion and the severable portion.
 9. An anastomosis device whichcooperates with a deployment tool for connecting an end of a graftvessel to a target vessel, the anastomosis device comprising: a firstportion deformable by the deployment tool to form a first flange; and asecond portion deformable by the deployment tool to form a second flangewhich together with the first flange connects the graft vessel to thetarget vessel, the second portion including deformable members whichcooperate with the deployment tool to form the second flange, whereinthe first and/or second portion includes a plurality of members arrangedin a configuration such that axial compression of the first and/orsecond portion forms the first and/or second flange.
 10. An anastomosisdevice which cooperates with a deployment tool for connecting an end ofa graft vessel to a target vessel, the anastomosis device comprising: afirst portion deformable by the deployment tool to form a first flange;and a second portion deformable by the deployment tool to form a secondflange which together with the first flange connects the graft vessel tothe target vessel, the second portion including deformable members whichcooperate with the deployment tool to form the second flange, andwherein the first portion includes a plurality of members arranged in aconfiguration such that an axial dimension of the first portion changesupon radial expansion of the first portion and the second portionincludes a plurality of members arranged in a configuration such thatradial expansion of the second portion does not cause formation of thesecond flange, and the second portion including pairs of axial memberswhich are closer together at a distal end thereof than at a proximal endthereof when the first flange is formed, and wherein the proximal endsof the pairs of axial members are joined by circumferentially extendingseverable members, the severable members separating a deployed portionfrom a severable portion when the second flange is formed.
 11. Ananastomosis device which cooperates with a deployment tool forconnecting an end of a graft vessel to a target vessel, the anastomosisdevice comprising: a first portion deformable by the deployment tool toform a first flange; and a second portion deformable by the deploymenttool to form a second flange which together with the first flangeconnects the graft vessel to the target vessel, the second portionincluding deformable members which cooperate with the deployment tool toform the second flange, and wherein the deployment tool includes anexpander which forms the first flange and a holder tube surrounding theexpander, the holder tube being fixedly attached to a proximal end ofthe anastomosis device.
 12. An anastomosis device which cooperates witha deployment tool for connecting an end of a graft vessel to a targetvessel, the anastomosis device comprising: a first portion deformable bythe deployment tool to form a first flange; and a second portiondeformable by the deployment tool to form a second flange which togetherwith the first flange connects the graft vessel to the target vessel,the second portion including deformable members which cooperate with thedeployment tool to form the second flange, and wherein the secondportion includes shearable connections, each shearable connectioncomprising one or more sections of material extending between an outerperiphery of a projection and an inner periphery of a recess withinwhich the projection is located, the shearable connections beingfractured when the second flange is formed.
 13. An anastomosis devicewhich cooperates with a deployment tool for connecting an end of a graftvessel to a target vessel, the anastomosis device comprising: a firstportion deformable by the deployment tool to form a first flange; and asecond portion deformable by the deployment tool to form a second flangewhich together with the first flange connects the graft vessel to thetarget vessel, the second portion including deformable members whichcooperate with the deployment tool to form the second flange, andwherein the second portion includes helical members having shearableconnections therealong, the helical members forming the second flangeduring rotation of the anastomosis device, the shearable connectionsbeing fractured when the second flange is fully deployed.
 14. Ananastomosis device deployment system for deploying an anastomosis devicewhich cooperates with a deployment tool for connecting an end of a graftvessel to a target vessel, the anastomosis device comprising: a firstportion deformable by the deployment tool to form a first flange; asecond portion deformable by the deployment tool to form a second flangewhich together with the first flange connects the graft vessel to thetarget vessel, the second portion including deformable members whichcooperate with the deployment tool to form the second flange, whereinthe deployment tool further includes a handle, the handle including camgrooves and a holder, the holder having a distal end configured to holdthe anastomosis device with an attached graft vessel; and an expanderpositioned within the holder and slidable with respect to the holder toa position at which the expander is positioned within the anastomosisdevice and radially expands the anastomosis device, and wherein theholder and expander have follower members engaged in the cam grooves tomove the holder and expander with respect to one another upon activationof a part of the handle.
 15. A medical device which cooperates with adeployment tool for delivering and deploying the medical device at asite in a living body, the medical device comprising: first and secondsections connected together by a frangible linkage, the frangiblelinkage being deformable by the deployment tool such that frangibleelements of the frangible linkage are broken and the first section isseparated from the second section.
 16. The medical device of claim 15,wherein the frangible elements include weakened areas which cause thefrangible members to bend when the frangible linkage is deformed by thedeployment tool.
 17. The medical device of claim 15, wherein thefrangible elements are located at pivot connections between the firstand second sections, the first and second sections being machined from asingle piece of metal and the pivot connections comprising thin sectionsof the metal extending between the first and second sections.
 18. Themedical device of claim 15, wherein the first section includes aplurality of axial members and struts arranged in a configuration suchthat an axial dimension of the first section changes upon radialexpansion of the first section.
 19. The medical device of claim 15,wherein the medical device comprises an anastomosis device and the firstsection includes hinged axial members which bend outwardly and formfirst and second flanges.
 20. The medical device of claim 19, whereinthe deployment tool includes an expander which forms the first flangeand a holder tube surrounding the expander, the holder tube engaging thesecond section and forming the second flange while separating the firstsection from the second section.
 21. The medical device of claim 19,wherein the first section includes a plurality of members which projectoutwardly during formation of the first flange.
 22. The medical deviceof claim 19, wherein the first section includes a plurality of axialmembers and struts arranged in a configuration such that radialexpansion of the first section does not cause formation of the secondflange.
 23. The medical device of claim 19, wherein the first sectionincludes a first linkage which forms the first flange and a secondlinkage which forms the second flange, the second linkage includingaxial members which are closer together at a distal end thereof than ata proximal end thereof when the first flange is formed.
 24. Theanastomosis device of claim 23, wherein the frangible elements comprisecircumferentially extending severable links which join proximal ends ofthe axial members, the severable links being detached from the secondsection when the second flange is formed.
 25. The medical device ofclaim 19, wherein the deployment tube includes an expander which formsthe first flange and a holder tube surrounding the expander, the holdertube engaging a proximal end of the second section when the secondflange is formed.
 26. The medical device of claim 19, wherein theanastomosis device is sized to fit in an incision in a target vesselsuch that the first flange comprises an inner flange which presses aportion of a graft vessel into intimate contact with an inner surface ofthe target vessel and the second flange comprises an outer flange whichpresses another portion of the graft vessel against an outer surface ofthe target vessel.
 27. The medical device of claim 19, wherein theanastomosis device is sized to fit in an incision in a target vesselsuch that the first flange comprises an inner flange which presses aportion of a graft vessel into intimate contact with an inner surface ofthe target vessel and the second flange comprises an outer flange whichpresses another portion of the graft vessel against an outer surface ofthe target vessel, the first portion including axially extending membershaving anchoring projections thereon, the axially extending membersbeing bendable radially outwardly when the inner flange is formed suchthat the anchoring points are embedded in an inner surface of the targetvessel.